POST MARKET CLINICAL FOLLOW UP (MEDDEV 2.12-2 May 2004) Dr. med. Christian Schübel

2007/47/EG – Änderungen Klin. Bewertung Historie: CETF – Report (2000) Qualität der klinischen Daten zu schlecht Zu wenige klinische Prüfungen Im Vorgriff auf die Revision der MDD publiziert: MEDDEV 2.7.1. – Clinical Evaluation MEDDEV 2.12-2 – Post Market Clinical Follow Up Abteilung: 27.03.2017

PMCF – MEDDEV 2.12-2 Post market surveillance may include: active supervision by customer surveys inquiries of users and patient literature reviews post market clinical follow up

2007/47/EG – Änderungen Klin. Bewertung Annex II: 5.2. The manufacturer must authorize the notified body to carry out all necessary inspections and supply it with all relevant information, in particular [...] the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation test, the solutions adopted in accordance with Annex I section(2), preclinical and clinical evaluation, post-market clinical follow-up and results of the post-market clinical follow up, if applicable

Klinische Daten – Anhang X Die klinische Bewertung und ihre Dokumentation müssen aktiv anhand der aus der Überwachung nach dem Inverkehrbringen erhaltenen Daten auf dem neuesten Stand gehalten werden Wird eine klinische Überwachung PMCF – Post Market Clinical Follow UP nach dem Inverkehrbringen […] nicht für erforderlich gehalten, muss dies ordnungsgemäß begründet und dokumentiert werden. MEDDEV 2.12-2 Abteilung: 27.03.2017

PMCF – MEDDEV 2.12-2 PMCF should always considered for devices where: In the case the assessment of a product is performed through the concept of equivalence (“literature route” !) identification of possible emerging risks is critical the evaluation of long term safety and performance is critical (implants !)

PMCF – MEDDEV 2.12-2 Criteria to identify emerging risk: innovation severity of the disease sensitive target population risky anatomical site well known risks from literature or marketed devices obvious discrepancy between the pre-market follow up timescale and the expected life of the product

PMCF – MEDDEV 2.12-2 All PMCF should be planned: form of extended follow-up of patients enrolled in the pre-market trials and/or a prospective study of a representative subset of patients after the device is placed on the market

PMCF – MEDDEV 2.12-2 This plan will need to take into account: Results of the clinical investigation including Adverse events identified Average life expectancy of the device The claims made by the manufacturer for the device Performances for which equivalence is claimed New information becoming available

PMCF – MEDDEV 2.12-2 No PMCF: Products for which the medium/long term clinical performance and safety is already known from previous use of the device or from fully transferable experience with equivalent devices (Products quoted as "equivalent" devices where reference product is subjected to PMCF)

PMCF – MEDDEV 2.12-2 Conclusion PMCF – Plan Follow up of a pre-market trial Post-market prospective trial (cave: national requirements!) The notified body should review the appropriateness of the plan and the procedures The follow-up should take into account the average life expectancy In the case the assessment of a product is performed through the concept of equivalence, PMCF should always be considered.

Post Market Clinical Follow Up Möglichkeiten eines PMCF: Fortführung einer klinischen Prüfung (z.B. Herzklappen) Planung einer neuen klinischen Prüfung, klinischen Studie (Achtung bei zusätzlichen invasiven oder belastenden Untersuchungen - MPG §23) Durchführung einer sogenannten Registry Abteilung: 27.03.2017

PMCF – MEDDEV 2.12-2 Requirements for documentation of Post Market Clinical Follow Up (PMCF) activities: NOTE: Results of PMCF and link to risk management are not addressed in MEDDEV 2.12-2

Post-Market Clinical Follow-Up PMCF – MEDDEV 2.12-2 Risk Management Post-Market Surveillance Post-Market Clinical Follow-Up Abteilung: 27.03.2017

Content of an integrated Risk Management File: NOTE: PMCF – MEDDEV 2.12-2 Content of an integrated Risk Management File: NOTE: Timeframes for Risk Management File update (addressed in RM SOP / RM Plan) should be in compliance with PMCF plan and design of clinical follow up studies